BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 716899 · Received May 15, 2006

    Report

    Report Number
    8010047-2006-00048
    Event Type
    Malfunction
    Date Received
    May 15, 2006
    Date of Event
    February 9, 2006
    Report Date
    April 7, 2006
    Manufacturer
    OLYMPUS OPTICAL CO.LTD.
    Product Code
    GCK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT ONE OF THEIR PATIENTS HAD CONTRACTED HEPATITIS C SEVERAL WEEKS AFTER HIS ENDOSCOPY PROCEDURE. THE USER FACILITY MENTIONED THAT THE SAME ENDOSCOPE HAD BEEN USED ON THE DAY PRIOR ON A PATIENT WHO WAS KNOWN TO BE POSITIVE FOR HEPATITIS. THE USER FACILITY HAS COLLECTED SAMPLES FOR GENOTYPE TESTING, BUT THE RESULTS ARE NOT AVAILABLE AT THIS TIME. THE USER FACILITY ALSO MENTIONED THAT THEY DON'T BELIEVE THAT THE PT CONTRACTED THE HEPATITIS C AT THEIR FACILITY BECAUSE THEY HAVE BEEN REPROCESSING ALL THEIR ENDOSCOPES AS RECOMMENDED BY OLYMPUS. THE USER FACILITY THEREFORE HAS CONTINUED TO USE THE ENDOSCOPE FOR PT EXAMINATIONS. THE USER FACILITY NOTES THAT NO ADD'L REPORTED INCIDENT HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GCK OLYMPUS OPTICAL CO.LTD. GIF-Q180 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN